Radioimmunoassay, Total Estrogens, Nonpregnancy
This device is a radioimmunoassay system used to measure total estrogen levels in serum from non-pregnant individuals, used in the evaluation of reproductive disorders, menstrual cycle assessment, and monitoring of hormone-related conditions such as hypogonadism or estrogen-secreting tumors. It is classified as FDA Class 1, the lowest risk category, requiring only general controls with no premarket notification. The product code is JMD, regulated under 21 CFR 862.1275, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JMD
- Device Class
- FDA class 1
- Regulation Number
- 862.1275
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.